Indications & Uses
Dancy is indicated for:
Pharmacology
Drospirenone is a progestin. It is used by females of reproductive potential to prevent pregnancy. As an oral contraceptive, it lowers the risk of becoming pregnant mainly by suppressing ovulation. Drospirenone is a spironolactone analogue and has anti-mineralocorticoid activity.
Absorption: After single oral doses from 1 to 10 mg, the pharmacokinetics of drospirenone are dose-proportional. Maximum plasma concentrations (Cmax) of about 27 ng/ml are reached roughly 2 to 6 hours after a single dose. During a treatment cycle, maximum steady-state serum concentrations of about 41 ng/ml are reached after about 10 days of treatment. Taking drospirenone with food has no influence on how much is absorbed.
Distribution: Between 95% and 97% of drospirenone is bound to serum albumin. It does not bind to sex hormone binding globulin (SHBG) or corticosteroid-binding globulin (CBG). The apparent volume of distribution is approximately 4 L/kg.
Metabolism: Drospirenone is extensively metabolized after oral administration. The two main metabolites found in human plasma are the acid form of drospirenone, which is generated when the lactone ring opens, and 4,5-dihydro drospirenone-3-sulfate, which is formed by reduction and then sulfation. Neither metabolite was shown to be pharmacologically active. Drospirenone also undergoes oxidative metabolism catalyzed by CYP3A4.
Excretion: Serum concentrations of drospirenone show a terminal disposition phase half-life of approximately 30 hours, after both single and multiple dose regimens. Excretion was nearly complete after ten days, and the amounts excreted were slightly higher in feces than in urine. Because drospirenone was extensively metabolized, only trace amounts of unchanged drospirenone were found in urine and feces.
Dosage Reference
Reference Information Only
Dosages shown are general references from official sources. Always consult your doctor or pharmacist for personalized dosing.
Detailed dosing reference is not available yet. Please follow your prescription and consult your pharmacist.
Side Effects
Some clinically significant side effects of drospirenone are described in other sections of the labeling. These are hyperkalemia, bleeding irregularities and amenorrhea. Clinical trials are run under widely varying conditions. Because of this, the adverse reaction rates seen in the trials of one drug can't be compared directly with the rates in the trials of another drug. They may also not match the rates seen in everyday practice. Adverse reactions reported: acne, metrorrhagia, headache, breast pain, weight increased, dysmenorrhea, nausea, vaginal hemorrhage, libido decreased, breast tenderness, menstruation irregularity.
Cautions & Contraindications
Warnings & Precautions
Hyperkalemia Drospirenone is a progestin with anti-mineralocorticoid activity. That includes a potential for hyperkalemia in high-risk females, comparable to a 25 mg dose of spironolactone. Drospirenone is contraindicated in females with conditions that predispose to hyperkalemia (e.g. renal impairment, hepatic impairment and adrenal insufficiency). Females who take medicines daily and long term for chronic conditions or diseases, where those medicines may raise serum potassium, should have their serum potassium checked before starting treatment and again during the first treatment cycle. Consider monitoring serum potassium in females at increased risk of hyperkalemia, meaning those who take a strong CYP3A4 inhibitor long term together with Drospirenone. Strong CYP3A4 inhibitors include azole antifungals (e.g. ketoconazole, itraconazole, voriconazole), HIV/HCV protease inhibitors (e.g., indinavir, boceprevir) and clarithromycin. Keep monitoring females on Drospirenone who later develop medical conditions and/or start medicines that put them at increased risk of hyperkalemia. Thromboembolic Disorders Epidemiological studies have not shown an association between progestin-only preparations and an increased risk of myocardial infarction, cerebral thromboembolism or venous thromboembolism. It is unknown whether the risk of VTE is higher with Drospirenone alone. If there is a risk, it is expected to be lower than that of Drospirenone combined with ethinyl estradiol. When prescribing Drosperinone, consider the higher risk of thromboembolism that comes with the postpartum period and with a history of thromboembolism. Discontinue Drosperinone if arterial or venous thromboembolic events occur. Consider stopping Drospirenone, if feasible, when there is prolonged immobilization due to surgery or illness. Bone Loss Treatment with Drospirenone lowers serum estradiol levels. It is unknown whether this can cause a clinically relevant loss of bone mineral density. Liver Disease Discontinue Drospirenone if jaundice or acute or chronic disturbances of liver function develop. Don't restart it until markers of liver function return to normal and Drospirenone has been excluded as the cause. Drospirenone is contraindicated in females with liver tumors, benign or malignant, or with hepatic impairment. Ectopic Pregnancy Be alert to the possibility of ectopic pregnancy in females who become pregnant, or who complain of lower abdominal pain, while on Drospirenone. Risk of Hyperglycemia in Patients with Diabetes Some patients taking progestins, including Drospirenone, may show a decrease in insulin sensitivity. So patients with diabetes may be at greater risk of hyperglycemia and may need further medicine adjustments or monitoring. Bleeding Irregularities and Amenorrhea Females using Drospirenone may have unscheduled (breakthrough or intracyclic) bleeding and spotting, especially in the first three months of use. Bleeding irregularities may settle over time, or by changing to a different contraceptive product. If bleeding continues, or appears after previously regular cycles, evaluate for causes such as pregnancy or malignancy. If scheduled bleeding does not occur, consider the possibility of pregnancy. If the patient has not followed the prescribed dosing schedule (she missed one or two active tablets, or started them on a later day than she should have), consider the possibility of pregnancy at the time of the first missed period and carry out appropriate diagnostic measures. If the patient has followed the prescribed dosing schedule and misses two consecutive periods, rule out pregnancy. Depression Carefully observe females who have a history of depression, and discontinue Drospirenone if depression recurs to a serious degree. Data on the link between progestin-only contraceptive products and the onset or worsening of depression are limited.
Contraindications
Drospirenone should not be used in people with renal impairment, adrenal insufficiency, or a presence or history of progestin sensitive cancers. It should also not be used in liver tumors, benign or malignant, or hepatic impairment, or in undiagnosed abnormal uterine bleeding.
Pregnancy & Breastfeeding
Studies and meta-analyses show little or no increased risk of birth defects in children born to women who take an oral progestin by mistake in early pregnancy. If pregnancy occurs, stop the medicine, because there is no reason to use hormonal contraceptives during pregnancy.
Only negligible amounts of Drospirenone pass into breast milk. So at therapeutic doses, no effects are expected in breastfed newborns or infants. In general, no adverse effects have been found on milk production, or on the health, growth or development of the infant, with the use of POPs.
⚠️ Talk to your doctor before taking any medicine during pregnancy or while breastfeeding.
Overdose
No serious harmful effects have been reported from an overdose of Drospirenone. Symptoms that can occur are nausea, vomiting and vaginal bleeding. There is no antidote, so treatment is symptomatic support only. Drospirenone is an analogue of spironolactone and has antimineralocorticoid properties. Because of this, serum potassium and sodium should be monitored in an overdose, and the doctor should also watch for signs of metabolic acidosis.
⚠️ In an emergency call 999 or go to the nearest hospital emergency department.
Storage
Store Drospirenone below 30°C in a dry place. Keep it away from light, and keep it out of the reach of children.
Drug Interactions
Common questions about Dancy 4 mg
What is Dancy 4 mg Tablet?
Dancy 4 mg Tablet is a medicine that contains Drospirenone. It is made by Ziska Pharmaceuticals Ltd. It belongs to the Oral Contraceptive preparations group of medicines.
What is Dancy used for?
Dancy is used for: Contraception.
What are the side effects of Dancy?
Some clinically significant side effects of drospirenone are described in other sections of the labeling. These are hyperkalemia, bleeding irregularities and amenorrhea.
Can I take Dancy during pregnancy or while breastfeeding?
Studies and meta-analyses show little or no increased risk of birth defects in children born to women who take an oral progestin by mistake in early pregnancy. If pregnancy occurs, stop the medicine, because there is no reason to use hormonal contraceptives during pregnancy. Talk to your doctor before taking any medicine during pregnancy or while breastfeeding.
What happens if I take too much Dancy?
No serious harmful effects have been reported from an overdose of Drospirenone. Symptoms that can occur are nausea, vomiting and vaginal bleeding. In an emergency call 999 or go to the nearest hospital emergency department.
How should I store Dancy?
Store Drospirenone below 30°C in a dry place. Keep it away from light, and keep it out of the reach of children.
Can I take other medicines with Dancy?
Some medicines can interact with Drospirenone, for example: Carbamazepine, Rifampicin, Omeprazole, Oxcarbazepine, Midazolam, Simvastatin. Tell your doctor or pharmacist about every medicine you take.
Do I need a prescription for Dancy?
Dancy is a prescription (Rx) medicine. Take it as your doctor advises.